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Could COVID-19 vaccines be swallowed?
New pre-clinical research demonstrates the potential of gastric autoinjectors to deliver mRNA in sufficient quantities for vaccination.
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National Institutes of Health (NIH)
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Many hands make light work: why the new Bespoke Gene Therapy Consortium is a godsend for ambitious biopharma teams
In late October, we learned that an exciting and ambitious new entity – the Bespoke Gene Therapy Consortium (BGTC) – had come into being in the US, designed to encourage the delivery of more gene therapies for rare diseases. The consortium is an interesting construct, headed and funded by the…
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FDA joins Bespoke Gene Therapy Consortium (BGTC) for rare diseases
The consortium also consists of 10 pharmaceutical companies and five organisations to accelerate gene therapies to treat rare diseases.
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Phase III clinical trial for respiratory syncytial virus (RSV) vaccine begins
Pfizer’s RENOIR Phase III trial will evaluate the efficacy, immunogenicity and safety of their respiratory syncytial virus (RSV) vaccine.
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Fostamatinib reduces COVID-19 risks by 50 percent in Phase II study
Fostamatinib significantly reduced serious adverse effects and risk of death in hospitalised COVID-19 patients, shows Phase II study.
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HIV vaccine fails to protect women against infection
The investigational vaccine tested in sub-Saharan Africa posed no safety concerns but did not provide sufficient HIV protection.
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Study shows no benefit of convalescent plasma for COVID-19 patients
An NIH trial found that COVID-19 convalescent plasma did not prevent disease progression in high-risk outpatients with early symptoms.
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Bamlanivimab and etesevimab prevent COVID-19 related deaths
In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
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US closes enrolment in two COVID-19 antibody studies due to futility
The sub-studies evaluating VIR-7831 and BRII-196 with BRII-198 have stopped enrolment based on recommendations from the Data and Safety Monitoring Board.
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NIAID stops HIV vaccine trial after review finds treatment ineffective
The US NIAID has stopped its HVTN 702 clinical trial for an HIV vaccine after an independent board found that the treatment did not prevent the condition.
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AI can predict which research will translate to clinical trials
Researchers have created an AI model that analyses the citations of studies, predicting their potential for eventual clinical application.
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Clinical trial tests injectable vs oral HIV medications
A new clinical trial will determine if monthly injections of anti-viral drugs are more effective at suppressing the HIV virus than daily pills.
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Formulation In-Depth Focus 2019
As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
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Acting FDA Commissioner named
As Dr Scott Gottlieb steps down from his role next month, Dr Ned Sharpless has been announced as his short-term replacement...
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Strong spending seen in US medical and health R&D over five-year period
The pharmaceutical industry accounted for 67 percent of the total spending on research and development, with federal government accounting for 22 percent...
